510(k) K101719
K101719 is an FDA 510(k) premarket notification submitted by Dalton Instrument Corp. for the device "TACAMO MANUAL WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on August 25, 2010. The device falls under product code IOR (Wheelchair, Mechanical), a Class I device regulated under 21 CFR 890.3850. Dalton Instrument Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2010
- Date Received
- June 18, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.